Bite block for respiratory and diagnostic endoscopic equipment

ABSTRACT

Certain embodiments are directed to a bite block device to protect patients oral cavity with interchangeable open or close configuration that allows placement after the insertion of scope or airway equipment. The equipment is made of one plastic material, embodied with functional plastic design components including living hinge, snap locks and interlocks.

PRIORITY PARAGRAPH

This Application claims priority to U.S. Provisional Application Ser.No. 63/039,567 filed Jun. 16, 2020, which is incorporated herein byreference in its entirety.

BACKGROUND

The present invention relates to medical equipment in the field ofairway management, cardiac diagnostic procedures, upper gastrointestinaldiagnostic procedures, and pancreatic diagnostic procedures.

During respiratory and endoscopic procedures, the endoscope or similarequipment is frequently damaged by the patient's dentition. Thepatient's lip, teeth, and tongue are often damaged by the manipulationof endoscopic equipment. A bite block prevents the patient from bitingon respiratory or endoscopic equipment and/or causing injury to thepatient. The currently available bite block is a closed ring of hardplastic material and requires the scope or respiratory equipment to beplaced through the bite block before the initiation of the procedure.

Safe intubation of the esophagus is a critical step to perform theprocedure and ideally once the endoscope is inserted in the esophagus itshould only be removed at the end of procedure. The passage of the scopeinto the esophagus can be difficult in certain patients and the biteblock must be placed in the patients mouth before the insertion of thescope. If the endoscope is inserted and the proceduralist forgets toplace the bite block the scope is totally removed and the procedurerepeated with the bite block in place. Multiple attempts can potentiallycause injury of oral cavity pharyngeal and laryngeal structures.

Certain endoscope apparatus is equipped with various functionalitiessuch as camera, light source, biopsy capabilities, ultrasoundtransducers, electromagnetic tracking features, etc. Scopes can beexpensive and costly to repair, thus damage prevention is beneficial andcost effective. In certain circumstances, a bite block is necessarywhere patients have altered mental status; a partial level ofconsciousness such as emerging from general anesthesia, partiallysedated in the intensive care unit; seizures; or uncooperative behavior.

In patients requiring invasive mechanical ventilation, the endotrachealtube provides a direct connection between the ventilator circuit andpatients trachea and lungs. The occlusion of the endotracheal tube canoccur secondary to the biting of a patient bite or kinking on the tubeon dentition. The disconnection or impedance of the endotracheal tubeshould be avoided to prevent deflation of the lungs and aerosolizationof infectious droplets. The currently available bite block requiresdisconnection of the endotracheal circuit for removal.

During general anesthesia, the disconnection of the endotracheal tubefrom the respiratory circuit can cause spilling of anesthetic gases inthe operating room environment. When emerging patients from generalanesthesia, biting the endotracheal tube is a common event insuperficial stages of anesthesia. The occlusion of the endotracheal tubeis associated with the extremely negative pressures generated by theattempt to breath and it causes alveolar damage; a complication known asnegative pressure pulmonary edema. This complication can be avoided byusing a bite block.

Bite blocks were designed for easy insertion and manipulation of anendoscope in short procedures such as upper endoscopy, therefore theyhave a large profile and may not fit in patients with a small mouth.Bite blocks may also be necessary for long periods of time. A regularbite block may not fit in a small mouth opening and if the placement istoo tight it may result in unwanted pressure injury to the teeth, gum,or lip. Moreover, when patients are intubated a good part of the oralcavity is occupied by the endotracheal tube. A bite block with a smallerprofile is useful when patients are intubated and require additionalendoscopy. In that circumstance it is difficult to use the regular biteblocks.

SUMMARY

The present invention provides a solution for the above-describedproblems and improves the functionality of bite block equipment. Thedevice described herein is a bite block that can be interchanged from anopen to a close configuration and vice-versa allowing the bite block topositioned around equipment after intubation or insertion through apatient's oral cavity. The bite block described herein can be placedaround the endoscopic or respiratory equipment either before or afterthe insertion of the scope and does not requiring disconnection of theendotracheal tube during placement or positioning of the device.

Certain embodiments are directed to a bite block comprising acomplementary first half component and second half component. The devicebeing configured to fold along a hinge to bring the two half componentstogether to form an operable bite block that can be reversible locked inan operable configuration during use. Each half component having a frontportion configured to be inserted in the oral cavity of a subject duringuse, a back portion configured to be external to the subject during use,a hinge side with a hinge side interface surface, a lock side with alock side interface surface, a concave semicircular interior surfacepositioned between the hinge side interface and the lock side interface,and an external surface. The first and second half component beingconnected by a hinge positioned on the hinge side of each component. Thehinge can be two-piece interlocking hinge or a flexible portionintegrated with both half components. In certain aspects the hinge in aportion of plastic that can be bent over on itself. The lock side ofeach half component has a portion of a complementary lock portion. Thelock portion can be a male, female, or can have both a male and femaleportion that complements a male, female, or a male and female portion onthe second lock side portion. The complementary half components can bepivoted at the hinge to bring the lock components in contact and theinterior surfaces in apposition forming a closed bite block having alumen from front to back.

In certain aspects, the bite block is a one-piece construction. The biteblock can be made of a plastic material.

The bite block can have complementary interlocks positioned on the hingeside interface. In certain aspects the interlocks can be a peg and holeinterlock configured, for example, to assist in alignment of the twohalf components.

The bite block is configured to be closed by manual approximation of thelock sides of each half of the device. The bite block is configured tobe opened by manual separation of the lock sides of each half of thedevice. The bite block is configured to provide an audible click or snapsound when the device is appropriately engaged in the closed position.

The bite block can have a rubberized external surface or rubberizedportions of the external surface to provide cushion and protectdentition from pressure damage during use.

In certain aspects, the bite block forms an external lip having a largerdiameter relative to the front portion.

Other embodiments of the invention are discussed throughout thisapplication. Any embodiment discussed with respect to one aspect of theinvention applies to other aspects of the invention as well and viceversa. Each embodiment described herein is understood to be embodimentsof the invention that are applicable to all aspects of the invention. Itis contemplated that any embodiment discussed herein can be implementedwith respect to any method or composition of the invention, and viceversa. Furthermore, compositions and kits of the invention can be usedto achieve methods of the invention.

The use of the word “a” or “an” when used in conjunction with the term“comprising” in the claims and/or the specification may mean “one,” butit is also consistent with the meaning of “one or more,” “at least one,”and “one or more than one.”

Throughout this application, the term “about” is used to indicate that avalue includes the standard deviation of error for the device or methodbeing employed to determine the value.

The use of the term “or” in the claims is used to mean “and/or” unlessexplicitly indicated to refer to alternatives only or the alternativesare mutually exclusive, although the disclosure supports a definitionthat refers to only alternatives and “and/or.”

As used in this specification and claim(s), the words “comprising” (andany form of comprising, such as “comprise” and “comprises”), “having”(and any form of having, such as “have” and “has”), “including” (and anyform of including, such as “includes” and “include”) or “containing”(and any form of containing, such as “contains” and “contain”) areinclusive or open-ended and do not exclude additional, unrecitedelements or method steps.

As used herein, the terms “comprises,” “comprising,” “includes,”“including,” “has,” “having,” “contains”, “containing,” “characterizedby” or any other variation thereof, are intended to encompass anon-exclusive inclusion, subject to any limitation explicitly indicatedotherwise, of the recited components. For example, a chemicalcomposition and/or method that “comprises” a list of elements (e.g.,components or features or steps) is not necessarily limited to onlythose elements (or components or features or steps), but may includeother elements (or components or features or steps) not expressly listedor inherent to the chemical composition and/or method.

As used herein, the transitional phrases “consists of” and “consistingof” exclude any element, step, or component not specified. For example,“consists of” or “consisting of” used in a claim would limit the claimto the components, materials or steps specifically recited in the claimexcept for impurities ordinarily associated therewith (i.e., impuritieswithin a given component). When the phrase “consists of” or “consistingof” appears in a clause of the body of a claim, rather than immediatelyfollowing the preamble, the phrase “consists of” or “consisting of”limits only the elements (or components or steps) set forth in thatclause; other elements (or components) are not excluded from the claimas a whole.

As used herein, the transitional phrases “consists essentially of” and“consisting essentially of” are used to define a chemical compositionand/or method that includes materials, steps, features, components, orelements, in addition to those literally disclosed, provided that theseadditional materials, steps, features, components, or elements do notmaterially affect the basic and novel characteristic(s) of the claimedinvention. The term “consisting essentially of” occupies a middle groundbetween “comprising” and “consisting of”.

Other objects, features and advantages of the present invention willbecome apparent from the following detailed description. It should beunderstood, however, that the detailed description and the specificexamples, while indicating specific embodiments of the invention, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

DESCRIPTION OF THE DRAWINGS

The following drawings form part of the present specification and areincluded to further demonstrate certain aspects of the presentinvention. The invention may be better understood by reference to one ormore of these drawings in combination with the detailed description ofthe specification embodiments presented herein.

FIG. 1 depicts a perspective view showing the bite block in openconfiguration—1-living hinge, 2-snap locks, 3-debossing interlocks4-embosses interlocks, 5-front rim, 6-internal surface in contact withthe scope or airway equipment.

FIG. 2 depicts a top view of showing—1-living hinge, 2-snap locks,3-debossing interlocks 4-embosses interlocks, 5-front rim, 6-internalsurface.

FIG. 3 depicts a bottom view of showing 1-living hinge, 5-front rim,7-external surface 8-back rim.

FIG. 4 depicts a front view of showing 1-living hinge, 2-snap locks,5-front rim, back rim

FIG. 5 depicts a back view of showing—1-living hinge, 2-snap locks,5-front rim.

FIG. 6 depicts a right lateral view of showing—2-snap locks, 3-debossinginterlocks, 4-embossed interlocks 5-front rim, 7-external surface 8-backrim.

FIG. 7 depicts a left lateral view of showing the bite block—2-snaplocks, 3-debossing interlocks 4-embossed interlocks 5-front rim,7-external surface 8-back rim.

FIG. 8 depicts a perspective view of showing the bite block in closeconfiguration. 1-living hinge, 2-snap locks, 5-front rim, 6-internalsurface, 5-front rim, 6-internal surface 7-external surface 8-back rim.

DESCRIPTION

The following discussion is directed to various embodiments of theinvention. The term “invention” is not intended to refer to anyparticular embodiment or otherwise limit the scope of the disclosure.Although one or more of these embodiments may be preferred, theembodiments disclosed should not be interpreted, or otherwise used, aslimiting the scope of the disclosure, including the claims. In addition,one skilled in the art will understand that the following descriptionhas broad application, and the discussion of any embodiment is meantonly to be exemplary of that embodiment, and not intended to intimatethat the scope of the disclosure, including the claims, is limited tothat embodiment.

The bite block described herein can has additional functional featuresand the same or equivalent structural strength compared with currentlyavailable bite blocks.

FIG. 1 depicts one example of a bite block in an open configuration. Thebite block is comprised of two “C” shape halves. In certain aspects thehalves are manufactured of hard plastic material. The halves areconnected by flexible hinge 1. The halves when moved to a closedposition form a lumen, e.g., turns into “O” shape through which a devicecan be positioned. A closed configuration is depicted in FIG. 8 . Thetransition in configuration (from an open device to a closed device) isaccomplished by three design features: connecting hinge 1, snap lock 2and structural interlocks 3,4.

The hinge between the two “C” halves keeps the parts always connectedand aligned during the transition from open to closed configuration andvice versa. The hinge can be intergarl to the manufacture of a one piecedevice or can be permanently attached to both halves of the device. Inthe close position the halves form a lumen, i.e., make a full ring, thatprovides the same functionality of a regular bite block, but allow theoptional removal of the device without removing or detaching a medicaldevice associated with the bite block. The lumen cross-section can be acircle, oval, ellipse, or other geometry.

In certain aspects, interlock bosses 3 and respective debosses 4 arepresent on both surfaces of the “C” halves interface (interfacesurfaces) to prevent the two parts from sliding when under pressure andto provide continuity of the structural strength to sustain pressure.

The locking mechanism 2 can be a snap lock that keeps the bite block inclose position preventing it from accidental opening. In certain aspectsthe lock provides an audible “click”, indicating the close configurationwas achieved. The lock can be disengaged or opened and the devicereturned to open configuration.

One advantage of the device described herein is the hinged bite blockcan be placed on a scope or an endotracheal tube after placement. Thereis no need for removal and reinsertion of the scopes, there is no needfor disconnection of endotracheal tubes and interruption of mechanicalventilation. The hinged bite block is placed around the tube, locked,and adjusted in the patient's mouth. Compared to the regular bite blocksthe hinge block has a smaller profile specifically designed for longstay without damage to the oral cavity.

In certain aspects the bite block has a soft cushion layer or pad on thesurface that directly contacts the front upper and lower teeth. Thiscushion layer is made of rubberized material such as thermoplasticpolyurethane (TPU), thermoplastic elastomer (TPE), or similar material.

In certain embodiments the bite block described herein is one singleplastic part with plastic design features that provide functionality tothe device. The living hinge 1 allows the transition in configurationfrom open to close position and vice-versa. The hinge is made of a thinamount of material that allows flexibility but tensile strength toprevent breakage.

The snap locks 2 keep the bite block in close configuration and preventit from spontaneously opening but allows manual opening and closing.

The bossing interlocks 3 and debosses 4 interlocks, allows alignment andstabilization when the two halves come together from open to closeconfiguration.

The front rim or lip 5 stabilizes the bite block between the patient'slips and prevents accidental dislodgement and migration of the biteblock into the oral cavity during the manipulation of the scope. Rim 8stabilizes the bite block between the patient's front upper and lowerteeth and prevents dislodgement and external migration.

Internal surface 6 where the scope is in contact, has a smooth surfacefinishing to prevent friction and potential damage to the scope surfacedwith multiple passes.

The external surface 7 where the patients front top and front bottomteeth will be in contact. The surface can be made of the same materialor preferably with a thin layer of rubberized material.

In certain aspects the internal diameter of the device when closed is,is at least, or is about 10, 12, 14, 16, 18, 20, to 22 mm. The externaldiameter of the body between the lip and the rim is, is about, or is atleast 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25,26, to 27 mm. The width of the body between the rim and the lip is, isabout, or is at least 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21,22, 23, 24, 25, 26, to 27 mm. The rim can have maximum diameter of, ofabout, or at least 22, 23, 24, 25, 26, 27, 28, 29, 30 mm (providing a 3,4, 5, 6, 7, to 8 mm projection from the body. The lip can have adiameter of 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37 38,39, to 40 mm (providing for a 12, 13, 14, 15, 16, 17, to 18 mmprojection from the body or the device. In certain aspects the thicknessof the walls of the device are 3 to 4 mm. In certain aspects the frontlip has a height of 14-16 mm, a width of 24-30 mm, thickness of 3 to 4mm. In certain aspects the rim has a height of 4-8 mm, a width of 15 to30 mm, and a thickness of 3-4 mm.

1. A bite block comprising a complementary first half component and second half component, each half component having a front portion configured to be inserted in the oral cavity of a subject during use, a back portion configured to be external to the subject during use, a hinge side with a hinge side interface surface, a lock side with a lock side interface surface, a concave interior surface positioned between the hinge side interface surface and the lock side interface surface, and an external surface; the first half component and the second half component being connected by a hinge positioned on the hinge side of each component, the lock side of each half component comprising a portion of a complementary lock, wherein the complementary half components can be pivoted at the hinge to bring lock components in contact and the interior surfaces in apposition forming a closed bite block having an elliptical lumen from front to back.
 2. The bite block of claim 1, wherein the bite block is a one-piece construction.
 3. The bite block of claim 2, wherein the bite block is a plastic material.
 4. The bite block of claim 1, further comprising complementary interlocks positioned on the hinge side interface.
 5. The bite block of claim 1, further comprising a rubberized external surface configured to cushion and protect dentition from pressure damage during use.
 6. The bite block of claim 1, the back portion forms an external lip having a larger diameter relative to the front portion.
 7. The bite block of claim 1, wherein the bite block made from a material having a durometer measurement of from 10 to
 80. 8. The bite block of claim 7, wherein the material comprises at least one material selected from urethane, polyurethane, ethylene, polyethylene, thermoplastic elastomer, and/or silicone.
 9. The bite block of claim 1 configured to be closed by manual approximation of the lock sides of each half of the bite block.
 10. The bite block of claim 1 configured to be opened by manual separation of the lock sides of each half of the bite block.
 11. The bite block of claim 1 configured to provide an audible click or snap sound when the device is appropriately engaged in the closed position.
 12. A method for protecting teeth and gums from clenching damage in a person requiring endotracheal tube administration, comprising the steps of inserting an endotracheal tube into a patient, once the endotracheal tube is appropriately inserted, surrounding a segment of the endotracheal tube using a bite block of claim 1 in an open configuration and locking the bite block in position such that the endotracheal tube passes through the bite block; and deploying the bite block to the interior of the patient's mouth.
 13. The method of claim 12, further comprising unlocking the bite block during a procedure, adjusting or altering the endotracheal tube, and locking the bite block in position after adjusting or altering the endotracheal tube.
 14. A one-piece bite block comprising a complementary first half component and second half component, each half component having a lipped front portion configured to be inserted in the oral cavity of a subject during use, a lipped back portion configured to be external to the subject during use, a hinge side with a hinge side interface surface and a lock side with a lock side interface surface both interface having complementary interlocks configured to minimize translation of the first half component and the second half component with respect to each other during use, a concave interior surface positioned between the hinge side interface surface and the lock side interface surface, and an external surface; the first and second half component being connected by a hinge positioned on the hinge side of each component, the lock side of each half component comprising a portion of a complementary lock configured to provide an audible click or snap sound when the device is appropriately engaged in the closed position, wherein the complementary half components can be pivoted at the hinge to bring lock components in contact and the interior surfaces in apposition forming a closed bite block having an elliptical lumen from front to back. 